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FDA 510(k)

Idys ALIF ZP 3DTi 医療設備規範文本

K 號:K200920 · 2020-05-29

決定日期2020-05-29
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

Idys ALIF ZP 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K200920. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Idys ALIF ZP 3DTi?

Idys ALIF ZP 3DTi is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Clariance, Sas. The 510(k) number is K200920.

When did Idys ALIF ZP 3DTi receive FDA 510(k) clearance?

Idys ALIF ZP 3DTi received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200920.

Who is the listed applicant for Idys ALIF ZP 3DTi?

The FDA 510(k) record lists Clariance, Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Idys ALIF ZP 3DTi?

The FDA product code for Idys ALIF ZP 3DTi is MAX.

其他以 Clariance, Sas 為申請人之記錄

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相關器械(代碼:MAX)

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官方來源

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